Home / 510(k) Clearances / K201520

510(k) K201520

The Alma Opus System, Colibri Applicator and Tips by Alma Lasers, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2021
Date Received
June 8, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Alma Lasers, Inc.

  • K250071 — Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories (September 24, 2025)
  • K251230 — The Alma Hybrid Laser System (May 21, 2025)
  • K243044 — Alma Harmony (April 11, 2025)
  • K233024 — Alma Harmony (February 8, 2024)
  • K230308 — Alma Harmony (March 1, 2023)
  • K230371 — The Alma Soprano Titanium (February 22, 2023)
  • K222064 — The Alma Soprano Titanium (October 12, 2022)
  • K212073 — Alma Diode Tabletop Laser (July 14, 2022)
  • K203441 — The Alma Hybrid Laser System (July 2, 2021)
  • K181298 — Harmony XL Multi-Application Platform (June 13, 2018)

Other clearances for product code GEI

  • K252487 — POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) (March 2, 2026)
  • K260287 — SP Electrocautery Device (SP20) (February 24, 2026)
  • K251813 — CURIS II RF Generator (REF 360100-05) (February 11, 2026)
  • K251836 — Dermatrix Duo (February 6, 2026)
  • K254290 — ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+ (January 30, 2026)
  • K254220 — Reusable 3 Button Fingerswitch Wand (January 27, 2026)
  • K251435 — InbellaIgnite RF System (January 27, 2026)
  • K251254 — Ignite RF System (January 15, 2026)
  • K251996 — ENTire IRE System (January 14, 2026)
  • K251988 — Boston iFace (Boston iFace) (January 12, 2026)